Adult Acute Lymphoblastic LeukemiaPhase 3LY01609NCT02072785
Phase III Study of Vincristine Sulfate Liposome For Injection In Adults With Naïve Acute Lymphoblastic Leukemia
A Phase 3 study testing Vincristine Sulfate Liposome and Vincristine Sulfate in people with Adult Acute Lymphoblastic Leukemia, run by Nanjing Luye Sike Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to determine whether vincristine sulfate liposome could reduce less peripheral neuropathy than vincristine sulfate,and be as effective as vincristine sulfate in adults with Naïve Acute Lymphoblastic Leukemia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adult Acute Lymphoblastic Leukemia
- What is being tested?
- Vincristine Sulfate Liposome and Vincristine Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Feb 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- De novo untreated ALL patients diagnosed by the bone marrow morphology, immunophenotype.
- 65 ≥ Age (years) ≥ 18 , male or female,
- ECOG Performance status of 0, 1, or 2.
- Patients must fulfill the following laboratory values
- Total bilirubin ≤2 ULN (corrected for same age)
- AST and ALT ≤3 ULN ( corrected for same ages)
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- Serum creatinine ≤2 ULN (corrected for same age)
- Didn't receive any of the following treatments within 4 weeks before inclusion: chemotherapy, radiotherapy, replacement therapy, operation, long term of glucocorticoid therapy（>5 days）.
- No neurological disorders, no nerve or muscle injury (motor and sensory nerve).
- Patient must sign the informed consent and obey the protocol.
Who cannot join
- Atopy or allergic to multiple medicines or excipients.
- With serious complications that affect compliance.
- Serious organ dysfunctions or central nervous system disorders.
- Mixed phenotype acute leukemia, (T-B).
- Burkitt lymphoma/leukemia.
- Suspected or confirmed central nervous system leukemia.
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- Diabetes.
- Received antifungal treatment with triazole agents within 1 month before inclusion.
- Reliance of antipyretic and analgesic medicines or psychotropic medicines.
- Undergoing or has undergone other clinical trials in 4 weeks before inclusion.
- Pregnant women, women of breast feeding or childbearing potential without contraception.
- Psychological disorders that affect signing consent.
- The investigators believe that patients who are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
Yingchang Mi, Doctor contact
China1 site, 1 recruiting
- Recruiting
Hospital of Blood Diseases, Chinese Academy of Medical Sciences
Tianjin, 300020
Yingchang MI, Doctor
About this study
Official title: Phase III Study of Vincristine Sulfate Liposome Or Vincristine Sulfate For Injection Combined Chemotherapy as Initial Induction Regimen In Adults Acute Lymphoblastic Leukemia
The purpose of this study is to determine whether vincristine sulfate liposome could reduce less peripheral neuropathy than vincristine sulfate,and be as effective as vincristine sulfate in adults with Naïve Acute Lymphoblastic Leukemia.
- Conditions
- Adult Acute Lymphoblastic Leukemia
- Being tested
- Vincristine Sulfate Liposome, Vincristine Sulfate
- Keywords
- Adult Acute Lymphoblastic Leukemia, Vincristine Sulfate Liposome, Vincristine Sulfate
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vincristine Sulfate LiposomeDrug
| Study group | Role | What they receive |
|---|---|---|
| Vincristine Sulfate Liposome | Experimental | Vincristine Sulfate For Injection simulation agent 1.4mg/m2,(2mg, maximum dose), iv, d1, d8, d15, d22. Vincristine Sulfate Liposome For Injection: 1.4mg/m2, (2mg, maximum dose), iv, d1, d8, d15, d22.
Duration between these two agents should be more than 2.5h, and saline should be avoided for flushing before Vincristine Sulfate Liposome For Injection. Receives: Drug: Vincristine Sulfate Liposome |
| Vincristine Sulfate | Active comparator | Vincristine Sulfate For Injection 1.4mg/m2,(2mg, maximum dose), iv, d1, d8, d15, d22. Vincristine Sulfate Liposome For Injection simulation agent: 1.4mg/m2,(2mg, maximum dose), iv, d1, 8, 15, 22.
Duration between these two agents should be more than 2.5h, and saline should not be used for flushing before Vincristine Sulfate Liposome For Injection simulation agent. Receives: Drug: Vincristine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate(objectives (ORR)
ORR=CR+CRi CR(Complete response)
- No circulating blasts or extramedullary disease, No lymphadenopathy,splenomegaly,skin/gum infiltration/testicular mass/CNS involvement
- Trilineage hematopoiesis(TLH)and <5% blast in bone marrow
- ANC>1000/microl
- Platelets>100,000/microl
CRi(Complete response with incomplete recovery of counts) Recovery of platelets but<100,000 or ANC is <1000/microl
Measured: up to 35 days
Incidence of General peripheral neuropathy
Chemotherapy-induced peripheral neuropathy was evaluated By Total Neuropathy Score clinical Version(TNSc).
If the score of any item of TNSc at anytime after the start of induction chemotherapy is higher than the baseline,it is considered that peripheral neuropathy occurs.
Measured: A week before enrollment. one,two,three and four weeks after the start of induction chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startJun 2013
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Luye Sike Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ethics Committee of Blood Diseases Hospital, Guangdong Provincial People's Hospital, Qilu Hospital of Shandong University, Xijing Hospital, Xinqiao Hospital of Chongqing, China Medical University, China, West China Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, The Second Hospital of Hebei Medical University, The First Affiliated Hospital of Zhengzhou University, Nanfang Hospital, Southern Medical University, First Affiliated Hospital of Harbin Medical University, Xuzhou Medical University, First Affiliated Hospital of Zhejiang University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072785
- Sponsor's protocol ID
- LUYESIKE-VSL-Ⅲ-01
- Acronym
- LY01609
- Status last verified
- Nov 2013
- First submitted
- 25 Feb 2014
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Vincristine Sulfate Liposome Or Vincristine Sulfate For Injection Combined Chemotherapy as Initial Induction Regimen In Adults Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT02072785
- Acronym / sponsor ID
- LY01609 / LUYESIKE-VSL-Ⅲ-01
- Conditions
- Adult Acute Lymphoblastic Leukemia
- Keywords
- Adult Acute Lymphoblastic Leukemia, Vincristine Sulfate Liposome, Vincristine Sulfate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Nanjing Luye Sike Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Ethics Committee of Blood Diseases Hospital, Guangdong Provincial People's Hospital, Qilu Hospital of Shandong University, Xijing Hospital, Xinqiao Hospital of Chongqing, China Medical University, China, West China Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, The Second Hospital of Hebei Medical University, The First Affiliated Hospital of Zhengzhou University, Nanfang Hospital, Southern Medical University, First Affiliated Hospital of Harbin Medical University, Xuzhou Medical University, First Affiliated Hospital of Zhejiang University
- Study start
- Jun 2013
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether vincristine sulfate liposome could reduce less peripheral neuropathy than vincristine sulfate,and be as effective as vincristine sulfate in adults with Naïve Acute Lymphoblastic Leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vincristine Sulfate Liposome | Experimental | Drug: Vincristine Sulfate LiposomeVincristine Sulfate For Injection simulation agent 1.4mg/m2,(2mg, maximum dose), iv, d1, d8, d15, d22. Vincristine Sulfate Liposome For Injection: 1.4mg/m2, (2mg, maximum dose), iv, d1, d8, d15, d22. Duration between these two agents should be more than 2.5h, and saline should be avoided for flushing before Vincristine Sulfate Liposome For Injection. |
| Vincristine Sulfate | Active comparator | Drug: Vincristine SulfateVincristine Sulfate For Injection 1.4mg/m2,(2mg, maximum dose), iv, d1, d8, d15, d22. Vincristine Sulfate Liposome For Injection simulation agent: 1.4mg/m2,(2mg, maximum dose), iv, d1, 8, 15, 22. Duration between these two agents should be more than 2.5h, and saline should not be used for flushing before Vincristine Sulfate Liposome For Injection simulation agent. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- De novo untreated ALL patients diagnosed by the bone marrow morphology, immunophenotype.
- 65 ≥ Age (years) ≥ 18 , male or female,
- ECOG Performance status of 0, 1, or 2.
- Patients must fulfill the following laboratory values
- Didn't receive any of the following treatments within 4 weeks before inclusion: chemotherapy, radiotherapy, replacement therapy, operation, long term of glucocorticoid therapy（>5 days）.
Key exclusion criteria (13 listed)
- Atopy or allergic to multiple medicines or excipients.
- With serious complications that affect compliance.
- Serious organ dysfunctions or central nervous system disorders.
- Mixed phenotype acute leukemia, (T-B).
- Burkitt lymphoma/leukemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vincristine Sulfate Liposome | Drug | Vincristine Sulfate Liposome |
| Vincristine Sulfate | Drug | Vincristine Sulfate |
Primary outcome
Overall response rate(objectives (ORR)
Time frame: up to 35 days
ORR=CR+CRi CR(Complete response) 1. No circulating blasts or extramedullary disease, No lymphadenopathy,splenomegaly,skin/gum infiltration/testicular mass/CNS involvement 2. Trilineage hematopoiesis(TLH)and <5% blast in bone marrow 3. ANC>1000/microl 4. Platelets>100,000/microl CRi(Complete response with incomplete recovery of counts) Recovery of platelets but<100,000 or ANC is <1000/microl
Incidence of General peripheral neuropathy
Time frame: A week before enrollment. one,two,three and four weeks after the start of induction chemotherapy
Chemotherapy-induced peripheral neuropathy was evaluated By Total Neuropathy Score clinical Version(TNSc). If the score of any item of TNSc at anytime after the start of induction chemotherapy is higher than the baseline,it is considered that peripheral neuropathy occurs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingchang Mi, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vincristine Sulfate Liposome and Vincristine Sulfate in people with Adult Acute Lymphoblastic Leukemia, run by Nanjing Luye Sike Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingchang Mi, Doctor (86-10-22-23909999), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate(objectives (ORR) (time frame: up to 35 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2014.